Category: Uncategorised

The Scottish Medicines Consortium (SMC) have announced that sotatercept, the ‘first in class’ PAH treatment, will not be commissioned for use by NHS Scotland at this stage.

Whilst this is disappointing news, it is not unexpected. Initial refusal is common for new and specialised drugs, and sotatercept is an expensive therapy – considerably higher than every other treatment that is currently available.

Issuing its guidance today, 9th February, the SMC wrote: "The submitting company did not present a sufficiently robust economic analysis to gain acceptance."

In August 2025, the same decision was made by the National Institute of Clinical Excellence (NICE) regarding its use in England. Following further submissions of evidence, a second appraisal committee meeting took place at the end of last year and we are still awaiting an outcome. It is likely that this will also be the next stage in the process for Scotland. MSD, the pharmaceutical company behind the drug, have indicated their intention to make a resubmission.

Here at the PHA UK we have been key stakeholders in the review process for both England and Scotland, presenting evidence of the impact of PAH gathered via our surveys and research.

This is by no means the end in terms of securing access to sotatercept, which has been submitted under the brand name of Winrevair. We have had to fight for every drug that’s currently used to treat pulmonary hypertension, and we will continue to use your voices to secure equity of access. We will keep you informed of developments.

Full details of the SMC guidance on sotatercept can be found here.

About sotatercept

Sotatercept is a totally new type of drug for pulmonary arterial hypertension. There are already a number of existing drugs that are known as ‘vasodilators’ – which work by opening up some of the arteries that have narrowed or closed down. But these drugs are treating the symptoms of PH, rather than what’s causing the disease.

Rather than just opening up vessels, sotatercept works more directly on the underlying ‘problem proteins’ that are causing the disease in the first place. It’s the first time a PAH drug is getting to the root cause of the problem, rather than treating the consequences of it. It must be remembered though that this is not a cure, so it is not a life-saving drug.

Sotatercept isn’t suitable for everyone. It is designed to be taken by some people alongside other medications, via an injection under the skin administered every three weeks.